Probe cover cassette with improved probe cover support

ABSTRACT

A cassette of tympanic thermometer probe covers includes a frame and probe covers releasably attached to the frame. The probe covers can be individually attached over a probe of a tympanic thermometer to protect the probe from contamination. The probe covers are constructed to releasably secure themselves to the probe. The force required to secure the probe covers to the frame is less that the force which is required to detach the probe covers from the frame so that the probe cover is held by the frame while being attached to the thermometer probe. The probe cover is connected to the frame by frangible connections that are arranged to inhibit pivoting of the probe cover when being attached to the thermometer probe. A method of securing a probe cover to a probe of a tympanic thermometer is also disclosed.

RELATED APPLICATIONS

This patent application is a continuation in part of United Statespatent application Ser. No. 11/286,620 filed in the United States Patentand Trademark Office on Nov. 23, 2005, which is a continuation in partof U.S. patent application Ser. No. 10/538,314, filed in the U.S. Patentand Trademark Office on Jun. 13, 2005, which is the U.S. National Stageapplication of PCT Application No. PCT/US2003/00224 filed Jan. 6, 2003,the entire contents of which are hereby incorporated by referenceherein.

FIELD OF THE INVENTION

The present disclosure generally relates to the field of biomedicalthermometers, and more particularly, to probe covers for a tympanicthermometer.

BACKGROUND OF THE INVENTION

Medical thermometers are typically used to facilitate the prevention,diagnosis and treatment of diseases, body ailments, etc. for humans andother animals. Doctors, nurses, parents, and other care providers usethermometers to measure a subject's body temperature. An accuratereading of a subject's core body temperature is needed for effective useand should be taken from the internal or core temperature of a subject'sbody. Several thermometer devices are known for measuring a subject'sbody temperature, such as, for example, glass, electronic, and ear(tympanic).

Tympanic thermometers are generally considered by the medical communityto be superior for taking a subject's temperature. Tympanic thermometersprovide rapid and accurate readings of core temperature, overcoming thedisadvantages associated with other types of thermometers. Tympanicthermometers measure temperature by sensing infrared emissions from thetympanic membrane (eardrum) in the external ear canal. The temperatureof the tympanic membrane accurately represents the body's coretemperature. Further, it only takes a few seconds to measure a subject'stemperature in this manner.

Known tympanic thermometers typically include a probe containing a heatsensor such as a thermopile, a pyroelectric heat sensor, etc. See, forexample, U.S. Pat. Nos. 6,179,785, 6,186,959, and 5,820,264. These typesof heat sensors are particularly sensitive to the eardrum's radiant heatenergy. The accuracy with which the sensing probe senses the infraredradiation emitted by the eardrum directly corresponds with the overallaccuracy, repeatability and usability of the tympanic thermometer. Thesensing probe must be sensitive to the low level of infrared energyemitted by an eardrum while providing a high degree of accuracy,repeatability and thermal noise immunity.

In operation, a tympanic thermometer is prepared for use and a probecover is mounted onto a sensing probe extending from a distal portion ofthe thermometer. The probe cover provides a sanitary barrier between thesubject and the thermometer. A practitioner or other care providerinserts a portion of the probe having the probe cover mounted thereoninto a subject's outer ear canal to sense the infrared emissions fromthe tympanic membrane. The infrared light emitted from the tympanicmembrane passes through a window of the probe cover to the sensingprobe. The window is substantially transparent to infrared radiation,thereby allowing infrared radiation from the tympanic membrane to passthrough the probe cover to the heat sensing probe of the thermometer.Although an open window would be suitable for taking a temperaturemeasurement, a film (e.g., a plastic film) having a thickness on theorder of the wavelength of radiation in the far infrared range typicallyspans the window to provide a sanitary barrier between the subject andthe probe.

The practitioner presses a button to cause the thermometer to take atemperature measurement. The microelectronics process electrical signalsfrom the heat sensor to determine eardrum temperature and render atemperature measurement in a few seconds or less. The probe is removedfrom the ear canal and the probe cover discarded. A new probe cover isused each time the thermometer is used with a new subject to reduce therisk of cross-contamination (e.g., spreading of pathogens) betweensubjects.

The thermometer may be used many different times. In a hospital or otherhealth care facility, for example, a thermometer may be used to measurethe temperature of up to a few dozen subjects each day. Thus, the careprovider needs a supply of probe covers to replace the used probecovers. A plurality of nested probe covers can be supplied to replaceused probe covers, for example as shown in U.S. Pat. No. 5,088,834. Theprobe covers in a nested stack are held together by gravity and/orfriction between adjacent probe covers. Nesting probe covers together inthis way is efficient use of space, but it has disadvantages. Forexample, it may be necessary to manually handle the probe covers toseparate them for attaching one of the probe covers to a thermometerprobe. This is undesirable because it is possible that pathogens orother contaminants could be transferred to the probe covers during thehandling. Further, the probe covers (particularly the film portionsthereof) are thin and can easily be damaged when handled manually. Ifthe damage results in rips or tears in the film, there is no sanitarybarrier between the subject and the thermometer probe. Even if thedamaged film is sufficiently intact to provide a barrier, distortions,wrinkling, and/or foreign substances can alter the way infraredradiation is transmitted through the film and can thereby decrease theaccuracy of the temperature measurement.

Some of the foregoing problems can be overcome by supplying a pluralityof probe covers that are arranged side-by-side. For example, a careprovider can carry a cassette comprising a plurality of probe coversreleasably attached to a frame. One such cassette is disclosed in U.S.Pat. No. 4,662,360, the disclosure of which is incorporated herein byreference. The probe covers of the cassette (shown in FIGS. 8-10 of the'360 patent) are connected to the frame by two frangible stems. Thisapproach has also been used by the FirstTemp Genius® tympanicthermometer system available from Tyco Healthcare of Mansfield, Mass.

The FirstTemp Genius® system comprises a tympanic thermometer and aholder that releasably holds the thermometer when it is not in use. Theholder has a storage compartment for holding a probe cover cassette. Thestorage compartment has an opening and is configured to hold thecassette so the open ends of the probe covers are accessible through theopening. When the thermometer is received by the holder, the cassettestored in the compartment is underneath the thermometer. Thus, onecassette can be stored in the compartment without interfering with theholder's ability to hold the thermometer. Inside the storage compartmentis a base defining a plurality of wells for receiving the releasablyattached probe covers. A probe cover can be put on the thermometer probeby inserting the probe into one of the releasably attached probe covers.The force of insertion causes the frangible stems to break, therebyreleasing the probe cover from its attachment to the frame before theprobe cover is secured to the thermometer probe. The user continues tomove the probe in the direction of insertion until a shoulder on theoutside of the probe cover contacts the base at the opening to the well.The probe cover is finally attached to the thermometer probe by usingthe thermometer probe to push the probe cover shoulder against theupward facing part of the base surrounding its well to apply asecurement force sufficient to secure the probe cover to the probe. Theforce required to secure the probe cover to the probe depends on severalvariables, including friction between the probe and probe cover, theforce required (if any) to expand the probe cover to fit on the probe,and the force required (if any) for the probe cover to push one or moreprobe cover ejectors to retracted positions. As the thermometer probe isinserted into the probe cover, retention bumps on the inside of theprobe cover slide past an annular ridge on the thermometer probe. Theprobe cover is retained on the thermometer probe by engagement of theretention bumps with the annular ridge and by friction between the probecover and thermometer probe. Once the probe cover is on the probe, thethermometer is ready for use. After a subject's temperature is taken,the probe cover is removed from the thermometer probe and discarded.

In general, it is desirable to make as efficient use of the probe coverstorage space in the holder as is practically possible. More efficientuse of space could result in a smaller overall size of the thermometersystem and/or increase the number of probe covers that can be suppliedwithout re-stocking probe covers. Moreover, it is also desirable to makeuse of probe covers with tympanic thermometer systems as user friendlyas possible. For example, some probe cover cassettes can be difficult toload in a holder because the releasably attached probe covers can swingout of alignment with the wells in the base of the holder. When thishappens, the probe covers have to be manually realigned before they canbe received in the wells, which is an inconvenience to the user and alsomakes it more likely that the probe covers will be contaminated. It isalso desirable to provide users tactile and other sensory feedback tofacilitate use of probe covers in a tympanic thermometer system.

Accordingly, there is a need for systems and methods for handling asupply of probe covers for use with a tympanic thermometer moreefficiently and conveniently.

SUMMARY OF THE INVENTION

In one aspect of the present invention, a cassette generally comprises aframe and a plurality of tympanic thermometer probe covers releasablyattached to the frame by at least one frangible connection. The at leastone frangible connection is constructed allow the respective probe coverto be detached from the frame upon application of a detachment force andto support the respective probe cover against pivoting relative to theframe when it is releasably attached to the frame.

In another aspect of the present invention, a cassette generallycomprises a frame and a plurality of tympanic thermometer probe coversreleasably attached to the frame. Each probe cover is attached to theframe by a frangible connection. The probe covers being configured forattachment to a probe of a tympanic thermometer upon application of asecurement force. The frangible connection being configured to releasethe respective probe cover from the frame upon application of adetachment force that is greater than the securement force whereby theprobe covers can be held by the frame while attaching to the thermometerprobe and detached from the frame after the probe cover is attached tothe thermometer probe.

In yet another aspect of the present invention, a method of securing aprobe cover to a probe of a tympanic thermometer generally comprisesinserting the probe into an open end of the probe cover while the probecover is releasably attached to a frame, the frame having a plurality ofother probe covers releasably attached thereto. The probe is moved intothe probe cover until the probe cover is deformed by application of atleast a securement force so as to resiliently bear against the probe forsecuring itself to the probe while the probe cover remains connected tothe frame. The probe continues to be moved into the probe cover with atleast a detachment force that detaches the probe cover from the frame.The detachment force is greater than the securement force.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective of one embodiment of a tympanic thermometersystem of the present invention;

FIG. 2 is a perspective of a probe cover cassette used in thethermometer system of FIG. 1;

FIG. 2A is an enlarged fragmentary view thereof,

FIG. 3 is a top plan view of the cassette shown in FIG. 2 stacked withanother substantially identical probe cover cassette;

FIG. 4 is a perspective of the stacked cassettes shown in FIG. 3;

FIG. 5 is a section of the stacked cassettes taken in the planeincluding line 5-5 of FIG. 3;

FIG. 6 is a section of the stacked cassettes taken in the planeincluding line 6-6 of FIG. 3;

FIG. 7 is a section of the stacked cassettes taken in the planeincluding line 7-7 of FIG. 3;

FIG. 8 is an end view of the stacked cassettes shown in FIGS. 3-7;

FIG. 8A is an end view similar to FIG. 8, but with the cassettes shownapart in preparation of stacking;

FIG. 9 is a fragmentary perspective of a portion of the stackedcassettes from a vantage point beneath the stacked cassettes;

FIG. 10 is a perspective of a holder of the tympanic thermometer system;

FIG. 11 is a perspective of the holder and two stacked cassettestherein;

FIG. 12 is a top plan view thereof;

FIG. 13 is a section of the thermometer system taken as indicated byline 13-13 of FIG. 12 and further illustrating the thermometer held inthe holder;

FIG. 14 is a section taken in the plane including line 14-14 of FIG. 12without the thermometer;

FIG. 15 is a perspective of the thermometer system showing a fragmentaryportion of the thermometer about to engage a probe cover of the upperstacked cassette;

FIG. 15A is a fragmentary section of a probe cover attached to thethermometer probe taken in a plane including a longitudinal axis of theprobe cover;

FIG. 15B is a section of the thermometer probe and attached probe covertaken in the plane including line 15B-15B on FIG. 15A;

FIGS. 16A-16D are partial, fragmentary sections illustrating a sequenceof operation for attaching a probe cover from the upper stacked cassetteto the thermometer probe; and

FIGS. 17A-17D are partial fragmentary sections similar to FIGS. 16A-16Dillustrating a sequence for attaching a probe cover from the lowercassette to the thermometer probe after the upper stacked cassette hasbeen used and removed from the holder.

Corresponding reference numbers designate corresponding parts throughoutthe drawings.

DETAILED DESCRIPTION

As used herein, the term “proximal” refers to the portion of a structurethat is closer to a practitioner in normal use, while the term “distal”will refer to the portion that is further from the practitioner innormal use. As used herein, the term “subject” refers to a human patientor other animal having its body temperature measured. The term“practitioner” refers to a doctor, nurse, parent or other care providerusing a tympanic thermometer to measure a subject's body temperature,and may include support personnel. The terms “upper”, “lower”, “top”,“bottom”, “side” and other words indicating or suggesting that an objecthas a particular orientation are used for convenience and are defined inreference to the orientation of the object as shown in the drawings.Those skilled in the art will understand that orientation relative tothe up and down directions is not important to operation of the presentinvention and that different orientations are within the scope of theinvention.

Referring now to the drawings, first to FIG. 1 in particular, oneembodiment of a tympanic thermometer system is generally designated 100.The thermometer system 100 comprises a tympanic thermometer 107, atleast one probe cover cassette 101, and a holder 301 for holding theprobe cover cassette(s) and thermometer. The holder 301 of theparticular embodiment of the thermometer system 100 shown in FIG. 1holds first and second stacked probe cover cassettes 101. When referringto a probe cover cassette or an element thereof, the suffix “a” appendedto the corresponding reference number indicates reference to an uppercassette stacked on top of a lower cassette and the suffix “b” appendedto the corresponding reference number indicates reference to a lowerstacked cassette having an upper cassette stacked above it. Thus, inFIG. 1, the upper cassette is generally designated 101 a and the lowercassette is generally designated 101 b. It is possible to stackcassettes more than two high, in which case at least one cassette willbe an upper and lower cassette at the same time. Accordingly, the termsupper cassette and lower cassette are not absolute and simply identify acassette in reference to its position relative to another cassette. Thethermometer system 100 optionally includes a storage container 111(e.g., shipping package) for containing at least two probe covercassettes 101 a′, 101 b′ stacked so at least one probe cover 105 a ofthe upper stacked cassette is nested within a probe cover 105 b of thelower stacked cassette. This disclosure will focus first on the probecover cassettes 101, and then on the other components of the thermometersystem 100.

FIG. 2 shows a probe cover cassette 101 of the thermometer system 100.The cassette 101 comprises a frame 103 and a plurality of tympanicthermometer probe covers 105 that are releasably attached to the frame.The cassette 101 is constructed to permit the cassette to be stackedwith another substantially identical cassette (as shown in FIGS. 3-9) sothat the plurality of releasably attached probe covers 105 nest with theprobe covers of the other cassette. The probe covers 105 in theembodiment shown in the drawings are described in detail in co-pendingand commonly-owned U.S. patent application Ser. No. 11/286,620, filedNov. 23, 2005, the contents of which are hereby incorporated byreference to the extent not inconsistent herewith. Each of the probecovers 105 generally comprises a tubular body 117 having an opening at aproximal end thereof for receiving the probe of a tympanic thermometer107, and a film-covered infrared-transparent window 119 at distal endthereof for permitting radiation from a subject's tympanic membrane topass through the window to the probe. The film 115 provides a sanitarybarrier between the thermometer probe and the subject. The particularprobe covers 105 shown in the drawings are constructed by securing aseparately formed film 115 to the distal ends of each of the tubularbodies 117. The film 115 of a probe cover 105 can be constructed from adifferent material than its body 117. For example, the film 115 can beconstructed from a lower density plastic (e.g., low density polyethylene(LDPE)) while the body 117 is constructed from a higher density plastic(e.g., high density polyethylene (HDPE)). However, the film 115 and body117 of one or more of the probe covers 105 can be constructed of thesame material and/or formed integrally together without departing fromthe scope of the invention

The frame 103 is preferably constructed of the same material as theprobe cover bodies 117. For example, the probe cover bodies 117 and/orframe 103 may be constructed of a moldable plastic material (e.g.,polypropylene, polyethylene, or HDPE). The frame 103 can be manufacturedtogether with the probe cover bodies 117 in an injection molding system.However, the frame 103 and probe cover bodies 117 can be manufactured inany manner and/or constructed of different materials without departingfrom the scope of the invention. The frame 103 of the embodiment shownin the drawings comprises a plurality of longitudinal supports 125 (SeeFIG. 2). Two of the longitudinal supports 125 form opposing side walls127 of the cassette 101. A cassette may include one or more intermediatelongitudinal supports (e.g., one or more longitudinal supports 125located between the side walls 127). The particular cassette 101 shownin the drawings, for example, has a single intermediate support 129. Thelongitudinal supports 125 are preferably generally parallel and spacedat about equal intervals. For instance, the intermediate longitudinalsupport 129 of the cassette 101 in the drawings is spaced about midwaybetween the two side walls 127. The longitudinal supports 125 of theillustrated embodiment extend the full length of the cassette 101;however one or more of the longitudinal supports may extend less thanthe full length of the cassette without departing from the scope of theinvention. The frame 103 also comprises two opposing end walls 131(broadly, end supports) connecting the ends of the longitudinal supports125. Although the longitudinal supports 125 of the embodiment shown inthe drawings form walls, it is understood that the longitudinal supportsmay be configured in other ways (e.g., as elongate bars) withoutdeparting from the scope of the invention.

The probe covers 105 are preferably arranged in one or more rows andpositioned between the longitudinal supports 125. The cassette 101 shownin the drawings has two rows of eight probe covers 105. The rows areseparated by the intermediate support 129. Thus, the cassette 101comprises a supply of sixteen probe covers 105. Increasing or decreasingthe number of intermediate supports facilitates arrangement of the probecovers 105 in different numbers of rows. In general, it is desirable todesign a cassette so the probe covers 105 thereof are arranged asclosely as is practically possible to make the most efficient use ofspace. In some cases (e.g., when the probe covers are at least partlyrounded on the outside) it is possible to decrease spacing betweenadjacent rows by offsetting the probe covers in one row with respect tothe probe covers in the adjacent row, as is shown in FIG. 3. Forexample, the longitudinal axes 141 of the probe covers 105 in one roware aligned with points (e.g., the midpoints) between two probe coversin an adjacent row. Further, the intermediate support 129 turns back andforth between the offset probe covers 105 of the two adjacent rows andthereby forms a plurality of concave surfaces 149. The probe covers 105are positioned adjacent the concave surfaces 149, allowing the overallspacing between the rows to be reduced. Reducing the spacing betweenadjacent rows allows the overall width of the cassette 101 to be reducedwithout reducing the number of rows or the size of the probe covers 105.

The longitudinal supports 125 and end walls 131 of the cassette 101extend down from the upper surface 155 of the cassette, which ispreferably contained substantially within a horizontal plane. Each ofthe probe covers 105 is releasably attached to the cassette 101 at theupper surface 155 of the cassette by a frangible connection 157 to theframe 103. The frangible connection 157 is constructed to allow theprobe cover 105 to be detached from the frame 103 upon application of adetachment force. However, the frangible connection 157 is constructedto support the probe cover 105 against pivoting relative to the frame103 while the probe cover is still attached to the frame. As shown inthe drawings and in particular FIG. 2A), the frangible connection 157preferably comprises three frangible stems 159 spaced generallyequidistantly around the perimeter of the respective probe cover 105 andconnecting the probe cover to the frame 103. The frangible stems 159 arepreferably positioned so at least one frangible stem 159′ is spaced awayfrom an imaginary line 161 containing the remaining frangible stems159″. This avoids the possibility that all of the frangible stems 159connecting one of the probe covers 105 to the frame 103 are containedsubstantially a single line, which in combination with the relativelylow rigidity of the frangible stems can permit the respective probecover 105 to pivot on that line relative to the frame 103. It will beunderstood that a frangible connection between the frame and a probecover may have more or less than three frangible stems without departingfrom the scope of the present invention. It is also understood thatother types of frangible connections (e.g., a frangible connectionformed by a ring gate of an injection molding apparatus) may support oneor more probe covers 105 against pivotal movement relative to the frame103. The detachment force required to detach a probe cover 105 from theframe 103 is preferably greater than a securement force required tosecure the probe cover to the thermometer 107, for reasons that will beexplained below.

The frame 103 includes reinforcing structures that counter the tendencyof the frame to deform upon application of the detachment force to oneof the probe covers 105. For example, a web 171 extends laterally alongthe upper surface 155 of the cassette 101 from each of the side walls127 toward the adjacent row of probe covers and lengthwise between theend walls 131 of the cassette. The webs 171 are shaped to form aplurality of spurs 173 extending laterally into the spaces betweenadjacent probe covers 105. Each spur 173 supports two frangible stems159, one connecting the spur to each of the two adjacent probe covers105 (see FIG. 2). One of the functions of the spurs 173 is to facilitatespacing the frangible stems 159 so they are spaced substantiallyequidistant around the circumferences of the probe covers 105. Forinstance, the spurs 173 facilitate connection of the frangible stems 159to the probe covers 105 at locations that are remote from the side walls127. The greatest lateral extent of the webs 171 away from the sidewalls of the cassette 101 is at the spurs 173. Between the spurs 173,the web 171 is configured to form a concave edge surface 175 generallymatching the contours of the perimeter of the probe cover 105. The web171 stiffens the side walls 127, and thereby stiffens the frame 103.

The frame 103 also comprises a plurality of cross braces 181 extendingbetween adjacent probe covers 105 in a row and connecting thelongitudinal supports 125 at various locations between the end walls 131of the cassette 101. The cross braces 181 also help limit twistingand/or deflection of the frame 103, including localized twisting and/ordeflection of the frame while the detachment force is being applied toan adjacent probe cover 105. The cross braces 181 shown in the drawingshave the form of a wall extending from one longitudinal support 125(e.g., from the side walls 127 at a location coinciding with a spur 173to the intermediate support 129). The cross braces 181 may have an archshape, as shown in FIG. 6. The arched configuration of the cross braces181 reduces the amount of material needed to make the cross braces ascompared to cross braces that are configured as a rectangular wall.Cross braces may have other shapes without departing from the scope ofthe invention. A cross brace can be positioned between each probe coverand its two neighbors in the same row. This would result in each probecover being adjacent two longitudinal supports and either two crossbraces or a cross brace and an end wall. However, it is not necessary toposition a cross brace between each and every probe cover in a row. Inthe embodiment shown in the drawings, for example, a cross brace 181 ispositioned between each probe cover 105 and only one of its twoneighbors in its row. Each row of the cassette 101 in the drawingsalternates between having a cross brace 181 between adjacent probecovers 105 in that row and having no cross brace between adjacent probecovers in that row. Consequently, each of the probe covers 105 isadjacent two of the longitudinal supports 125 and at least one crossbrace 181 or an end wall 131 of the cassette 101. Even fewer crossbraces can be used without departing from the scope of the invention.

The frame 103 still further comprises a plurality of flanges 191extending horizontally from the longitudinal supports 125 (e.g., fromthe side walls 127). The flanges 191 are similar to the cross braces181, except that they do not extend all the way from the side wall 127to the intermediate support 129, and are preferably rectangular inshape. The flange 191 shown in FIG. 7, for example, comprises agenerally rectangular wall extending generally perpendicularly inwardfrom one of the side walls 127 (e.g., at a location coinciding with oneof the spurs 173). Each spur 173 of the cassette 101 shown in thedrawings is supported by either a cross brace 181 or a flange 191. Likethe cross braces 181, the flanges 191 help the frame 103 resist twistingand/or deflection, including localized twisting and/or deflection of theframe while an adjacent probe cover 105 is being detached from theframe. As best seen in FIG. 9, the cassette 101 shown in the drawingscomprises a plurality of flanges 191 extending from each of the sidewalls 127 at intervals coinciding with gaps between the cross braces181. Consequently, each of the side walls 127 comprises an alternatingseries of cross braces 181 and flanges 191 for stiffness reinforcement.A greater or lesser number of flanges than is shown in the illustratedembodiment can be used without departing from the scope of theinvention.

The intersections between the cross braces 181 with the respective sidewalls 127 and web 171 as well as the intersections between the flanges191 and the respective side walls and web each are defined by threeintersecting walls. Because the three walls (i.e., the side wall 127,the laterally extending web 171 and the cross brace 181 or flange 191)at the intersections are oriented in three different planes, theintersections provide additional resistance to twisting and/ordeflection of the frame 103. Preferably, the three walls meeting at eachof the intersections are in substantially mutually orthogonal relationto one another at the intersections as shown in FIG. 9. The variousreinforcing features of the frame 103 (including the longitudinalsupports 125, webs 171, cross braces 181, flanges 191, and thearrangement thereof in which three walls intersect at a plurality oflocations on the frame) in combination make the frame much stiffer thanthe frames of the prior art probe cover cassettes. This additionalstiffness is advantageous because it alleviates the need to decidebetween providing external support for the frame 103 while a detachmentforce is being applied to one of the probe covers 105 or accommodatingsubstantial twisting and/or deflection of the frame when a probe coveris being detached therefrom.

The frame 103 also has plurality of legs 211 (e.g., four legs) disposedto engage a generally flat surface 213 and hold the probe covers 105spaced away from that surface, as shown in FIG. 5. Holding the probecovers 105 spaced away from the surface 213 helps protect the probecovers, in particular the film 115, from damage and/or contaminationfrom the surface (e.g., when the cassette is placed on a work surface).The legs 211 are shaped and arranged to receive a frame of asubstantially identical cassette when stacked therewith. For example,the legs 211 of the cassette 101 shown in the drawings angle generallyoutward. This allows the legs 211 a of a substantially identicalcassette 101 a stacked on top of a lower cassette 101 b to overlay thelegs 211 b of the lower cassette, as best seen in FIG. 4.

The frame 103 also comprises a cassette aligning system 221 thatfacilitates bringing a substantially identical cassette into substantialalignment with and/or into a substantially similar orientation as thecassette 101 during stacking. As shown in FIGS. 8 and 8A, in oneembodiment the cassette aligning system 221 comprises at least onetapered guide wedge 223 and at least one tapered notch 225 in the frame103 (e.g., on one of the sides or ends of the cassette). The wedge 223includes a pair of walls 227 that are located generally between the legs211 and are spaced apart laterally of each other. The walls 227 divergefrom each other from the top of the cassette 101 to the bottom of thecassette. The notch 225 is defined on its laterally opposite sides bylower portions of the walls 227 of the wedge 223, and generally tapersfrom a greater width at an open end at the bottom of the cassette 101 toa lesser width at an upper end of the notch. The upper end of the notch225 can be closed as shown in the drawings or open. When the uppercassette 101 a is lowered onto the lower cassette 101 b for stacking(e.g., from the position shown in FIG. 8A), the notch 225 a of the uppercassette 101 a receives the upper ends of the walls 227 b of the guidewedge 223 b of the lower cassette 101 b. As the upper cassette 101 amoves further downward on the lower cassette 101 b, the interiorsurfaces of the walls 227 a of the guide wedge 223 a of the uppercassette engage exterior surfaces of the walls 227 b of the guide wedge223 b of the lower cassette 101 b. This engagement results in lateralalignment of the upper and lower cassettes 101 a, 101 b as they arestacked. The engagement of the legs 211 a, 211 b on oppositelongitudinal ends of the cassettes 101 a, 101 b produces longitudinalalignment of the stacked cassettes. It will be appreciated that becausethe legs 211 a, 211 b flare outwardly in a longitudinal direction awayfrom the ends of the cassettes 101 a, 101 b toward the bottom of thelegs, that the cassettes are initially easy to mate upon stacking. Thelower ends of the legs 211 a of the upper cassette 101 a are spreadapart more widely than the upper ends of the legs 211 b of the lowercassette 101 b. However, as the cassettes 101 a, 101 b move closertogether, the legs 211 a, 211 b engage and more precisely align thecassettes.

The frame 103 is preferably configured to maintain a minimum spacingbetween nested probe covers 105 a, 105 b of stacked cassettes 101 a, 101b. In the embodiment shown in the drawings, for example, the uppercassette 101 a has longitudinal supports 125, flanges 191, and downwardfacing surfaces at the narrow end of the notches 225 of the cassettealigning system 221 that are configured to engage the frame 103 b of thelower cassette 101 b and maintain spatial separation between the probecovers 105 a, 105 b of the upper cassette and lower cassette 101 b. Thecontact between the frames 103 a, 103 b of the upper and lower cassettes101 a, 101 b is distributed over a large portion of the cassettes. Forinstance, the contact between the frames 103 a, 103 b of the embodimentshown in the drawings is distributed along the longitudinal supports 125(e.g., the side walls 127 and intermediate/central support 129), flanges191, and the alignment systems 221 on the end walls 131. Thisdistribution of the contact between the upper and lower cassettes 101 a,101 b is advantageous because rather than being concentrated in arelatively small part of the frame 103, which would decrease the amountof force required to cause failure, the force required to maintainseparation between the probe covers 103 (e.g., while one of the probecovers is being detached from a stacked cassette 101) is distributedmore evenly throughout the frame. There are many other ways to configurea frame of a cassette so that it engages a frame of another cassette tomaintain spatial separation of nested probe covers without departingfrom the invention, including using different combinations of one ormore elements of the frame shown in the drawings and/or different frameelements other than the elements shown in the drawings (e.g., a separatespacer, not shown) to maintain spatial separation between nested probecovers.

The cassette 101 is also designed so that it can be stacked with anothersubstantially identical cassette in either of two differentorientations. For instance, the cassette 101 shown in the drawings hasradial symmetry about an axis 261 (FIG. 3) parallel to the longitudinalaxes 141 of the probe covers 105. Accordingly, if the cassette 101 hasan orientation relative to another cassette that permits stacking of thetwo cassettes, the cassette will also have an orientation relative tothe other cassette that permits stacking of the cassettes when thecassette is rotated on the axis 261 through an angle of about 180degrees. In the embodiment shown in the drawings, for example, the uppercassette 101 a can be stacked with the lower cassette 101 b in either oftwo orientations that are about 180 degrees apart. This makes handlingthe cassette 101 more convenient because a user is not required torotate the cassette more than ninety degrees on the axis 261 to bringthe cassette into one of the orientations suitable for stacking thecassette with another substantially identical cassette.

The cassette 101 further comprises a grip 271 (See FIG. 4) forseparating the cassette from other cassettes in a stack of cassettes. Ingeneral, the grip 271 is a feature of the cassette 101 that allows apractitioner to feel the boundary(ies) between two or more stackedcassettes and then grip the desired number of cassettes to separate themfrom the rest of the stack. For example, the grip 271 may comprise oneor more ridges 273 on the sides of the frame 103, as shown in FIG. 4. Inthe particular cassette 101 shown in the drawings, portions of the sidewalls 127 extending down from adjacent the upper surface 155 of thecassette under the ridges 273 define recessed areas 275. Consequently,the ridges 273 extend laterally outward above the recessed areas 275 ofthe side walls. When a substantially identical upper cassette 101 a isstacked on top of the lower cassette 111 b, the ridges 273 b of thelower cassette extend laterally from below the recessed areas 275 a ofthe side walls 127 of the upper cassette 101 a, allowing thepractitioner to run one or more fingers along either the side of thecassette to feel the ridge and identify the boundary between stackedcassettes. Likewise the practitioner can hold one or more ridges 273 aof the upper cassette 101 a with one hand and hold one or more ridges273 b of the lower cassette 101 b with the other hand to facilitatepulling the cassettes apart. Laterally projecting ridges can extendoutward from the side walls to form grips without any recesses beingassociated therewith within the scope of the invention. However, usingrecessed areas 275 of the side walls 127 to define the ridges 273 forthe grips 271 allows the grips to be formed without increasing theoverall width of the cassette 101.

The cassette 101 also comprises one or more detent receptacles 281 forreleasably receiving a detent from a retaining mechanism in a holder. Alip 283 (FIG. 2) is defined by the lower end of the receptacle 281. Inthe embodiment shown in the drawings, there are a total of four suchreceptacles 281, each of which defines a lip 283. Two of the receptacles281 are on each of the side walls 127, one to the right and one to theleft of the recessed areas 275 of the side walls under the grip 271.These receptacles 281 and lips 283 can be used to snap the cassette intoa holder, as will be described hereinafter.

FIGS. 3-9 show one embodiment of a combination of upper and lowerstacked cassettes 101 a, 101 b according to the present invention. Theprobe covers 105 a of the upper cassette 101 a are nested with alignedprobe covers 105 b of the lower cassette 101 b. The guide wedges 223 bof the cassette aligning systems 221 b of the lower cassette 101 b arereceived in the corresponding notches 225 a of the cassette aligningsystem 221 a of the upper cassette 101 a. The frame 103 a of the uppercassette 101 a is in contact with the fame 103 b of the lower cassette101 b, thereby holding the probe covers 105 a of the upper cassettespaced away from the probe covers 105 b of the lower cassette. As shownin FIGS. 5-8, for example, the upper cassette's 101 a longitudinalsupports 125 a, including the two side walls 127 a and the intermediatesupport 129 a, the flanges 191 a, and the downward facing surfaces ofthe aligning system 221 a engage the frame 103 b of the lower cassette101 b and prevent further movement of the upper cassette toward thelower cassette. It is apparent from the two stacked cassettes 101 a, 101b that any number of cassettes can be stacked together in this manner toform a single stack.

FIG. 10 shows one embodiment of a holder 301 that may be used to holdone or more cassettes 101. The holder 301 comprises a base 303 defininga plurality of wells 305 for receiving at least the distal ends of theprobe covers 105 and a housing 307 at least partially enclosing the base303. For example, the holder 301 may be used to hold the two stackedcassettes 101 a, 101 b (as shown in FIGS. 11-15) so at least the distalends of the probe covers 105 b of the lower stacked cassette arereceived in the wells 305. The base 303 comprises an upper surface 311similar to the upper surface 155 of the cassette 101. As shown in FIG.10, for example, the upper surface 311 of the base is engaged by theframe 103 b of the lower cassette 101 b in a manner similar to the waythe upper surface 155 b of the lower cassette is engaged by the frame103 a of the upper cassette 101 a. When the probe covers 105 b of thelower cassette 101 b are placed in the wells 305, the side walls 127 band intermediate support 129 b of the lower cassette engage the uppersurface 311 of the base 303 and hold the probe covers 105 b spaced abovethe bottoms of the wells. Contact between the upper surface 311 of thebase 303 and the frame 103 b of the lower cassette 101 b is alsoanalogous to the contact between the upper cassette 101 a and the lowercassette in that it is widely distributed over the cassette so the forceapplied to the lower cassette 101 b by the base 303 (e.g., to preventthe lower cassette 101 b from deflecting in a direction toward the basewhile a probe cover 105 b is being detached) is not concentrated in aparticular portion of the cassette.

The holder 301 also has a cassette retaining system 315 (FIG. 10)operable to hold one or more cassettes 101 in the holder. The retainingsystem 315 comprises eight detents 317 positioned to be received in acorresponding one of the detent receptacles 281 a, 281 b in the frames103 a, 103 b of the upper and lower cassettes 101 a, 101 b. It isunderstood that any number of detents (including only one detent) may beused within the scope of the invention. The holder 301 shown in thedrawings is designed to hold two stacked cassettes 101 a, 101 b. Whenused to hold two stacked cassettes 101 a, 101 b it is preferable for theretaining system 315 to comprise at least one detent 317 b positioned tobe received in one of the detent receptacles 281 b in the lower stackedcassette 101 b and at least one detent 317 a positioned to be receivedin one of the detent receptacles 281 a in the upper stacked cassette 101a. Still more preferably, the retaining system 315 comprises a pluralityof detents 317 b positioned to be received in corresponding receptacles281 b of the lower stacked cassette 101 b and a plurality of detents 317a positioned to be received in corresponding receptacles 281 a of theupper stacked cassette 101 a. For example, the holder shown in thedrawings has eight detents 317 on the inside of the housing 307 andpositioned so four of the detents 317 b can be received in the fourreceptacles 281 b of the lower stacked cassette 101 b and the remainingfour detents 317 a are received in the four receptacles 281 a of theupper stacked cassette 101 a. Each of the detents 317 a, 317 b and/orthe frames 103 a, 103 b of the cassettes 101 a, 101 b are constructed todeform when the cassettes are loaded in the holder 301 to permit thelips 283 a, 283 b on the side walls 127 a, 127 b of the cassettes toslide past the detent(s) to snap the cassette into the holder.

The housing 307 is configured to extend somewhat above the upper surface155 a of the upper cassette 101 a but may extend only to a locationsomewhat below the upper surface of the upper cassette or to a locationthat is even therewith within the scope of the invention. For example,the housing 307 may extend a short distance above the upper surface 155a of the upper stacked cassette 101 a. This upper end 325 of the housing307 forms a cradle for receiving a tympanic thermometer 107 as shown inFIG. 13. Thus, in contrast to the prior art holders, it is possible tostore more than one cassette (e.g., two cassettes) in the holder withoutinterfering with the ability of the holder to hold a tympanicthermometer at the same time. Consequently, the thermometer system 100has the capacity to contain a larger supply of probe covers 105 (e.g.,at least 22 probe covers and more preferably 32 probe covers) than priorart thermometer systems. The housing 307 is further configured to a pairof aligned, generally U-shaped cutaways 331 in the housing extendingdown from the upper end 325 of the holder 301 in registration with thegrips 271 of the two stacked cassettes 101 a, 101 b when the cassettesare received in the holder (FIG. 11). For example, the housing 307 ofthe holder 301 shown in the drawings defines two cutaways 331, one oneach side of the holder in registration with the side walls 127 of thecassettes 101 a, 101 b. The cutaways 331 are deep enough to allow thegrips 271 of both upper and lower cassettes 101 a, 101 b, to be accessedthrough the cutaways. The cutaways 331 are also preferably wide enoughto permit a health care provider to pass at least one finger througheach of the cutaways. Other arrangements and configurations of thecutaways are permitted within the scope of the invention.

When the cassettes 101 a, 101 b are loaded in the holder 301, there ispreferably only a slight separation between the probe covers 105 a, 105b of the upper and lower cassette and also only a slight separationbetween the probe covers of the lower cassette and their respectivewells 305. This, in combination with the frangible connections 157 ofthe probe covers 105 to the frame 103, helps limit pivotal movement ofthe probe covers 105 relative to the frame. The probe covers 105 a ofthe upper cassette 101 a can only pivot a relatively small amountrelative to the frame 103 a before the distal end of the probe covercontacts the probe cover 105 b of the lower cassette with which it isnested. Further pivotal movement of the upper probe cover 105 a wouldrequire movement of the probe 105 b of the lower cassette with which itis nested. Likewise, the relatively small separation between the probecovers 105 b of the lower cassette 101 b and their respective wells 305,in combination with the frangible connections 157 of the probe covers tothe frames, limits pivotal movement of the probe covers 105 b relativeto the frame 103 b. Pivotal movement of the probe cover 105 b relativeto the frame will bring the distal end of the probe cover into contactwith the side of the well, which will substantially prevent furtherpivotal movement of the probe cover. Thus, if the probe of the tympanicthermometer 107 is carelessly inserted into the open end of a probecover 105 without proper alignment or with a rotational motion thattends to cause pivotal movement of the probe cover relative to theframe, the well 305 (and the probe cover 105 b of the lower cassette, ifthe probe cover is attached to the upper cassette 101 a) will provideadditional support against pivotal movement of the probe cover. Thishelps the user bring the thermometer probe into alignment with thelongitudinal axis 141 of the probe cover as required for proper mountingof the probe cover on the thermometer. It also reduces the risk that oneof the frangible stems 159 will be broken before the others, which wouldmake it more difficult to mount the probe cover on the thermometerproperly. This, in combination with the tapered shape of the probe coverbodies 117, allows a thermometer probe to be inserted into the open endof one of the probe covers to secure the probe cover to the thermometereven when the alignment of the thermometer probe deviates from thelongitudinal axis 141 of the probe cover.

The cassettes 101 a, 101 b are preferably designed to be used with aparticular type of tympanic thermometer 107. This allows the probecovers 105 to be constructed in view of the particular configuration ofthe thermometer probe 351 so the force required to secure a probe coverto the probe is less than the detachment force required to detach aprobe cover from the frame 103. It also allows the frame 103 to beconfigured to limit movement of the thermometer probe 351 relative tothe cassette 101 in the direction of insertion of the probe into one ofthe probe covers 105.

There are many ways to limit movement of the thermometer probe 351relative to the cassette 101 in the direction of insertion of the probeinto one of the probe covers 105. As shown in FIG. 16C for example, anopening 353 is created in the upper surface 155 of the cassette 101 bydetachment of a probe cover 105 therefrom. The cassette 101 isconfigured so that the opening 353 created by removal of one of theprobe covers 105 is sized and shaped to permit the distal end of thethermometer 107 to pass through the opening, but to limit the extent towhich the distal end of the thermometer can pass therethrough.Preferably, the cassette 101 is configured to substantially prevent oneof the probe covers 105 b on a lower stacked cassette 101 b from beingaccidentally detached while the thermometer probe 351 is inserted into aprobe cover 105 a of the upper stacked cassette 101 a and used to detachthe probe cover from the frame 103 a of the upper cassette. Thethermometer 107 shown in the drawings comprises a thermometer probe 351extending distally from a thermometer body 357. A first (“distal”)annular shoulder 365 is formed at the distal end of the thermometer body357. The first annular shoulder 365 is sized and shaped to abut aproximal end 367 of the probe cover 105 when it is secured over thethermometer probe 351 and still attached to the cassette 101, and thenapply the detachment force to the probe cover. Further the first annularshoulder 365 is sized and/or shaped so it can pass through the opening353 in the cassette 101 created by detachment of a probe cover 105therefrom. The thermometer body 357 is shaped to form a second(“proximal”) annular shoulder 371 a short distance proximally from thefirst annular shoulder 365 that abuts the proximal end 367 of the probecover 105. The first annular shoulder 365 projects distally from thesecond annular shoulder 371 a distance D (see FIG. 16D) that is lessthan the distance between nested probe covers 105 a, 105 b of thestacked upper and lower cassettes 101 a, 101 b. The circumference of thesecond annular shoulder 371 is larger than the circumference of thefirst annular shoulder 365. Further, the second annular shoulder 371 issized and/or shaped so it will not fit through the opening 353 in thecassette 101 created by detachment of a probe cover 105 from the frame103. Instead of passing through that opening 353, the second annularshoulder 371 engages the upper surface 155 of the cassette 101 (e.g.,the web 171, intermediate longitudinal support 129, and if the detachedprobe cover is at the end of a row one of the end walls 131), whichstops movement of the thermometer 107 in the direction of insertion. Thedistance D that the first annular shoulder 365 projects from the secondannular shoulder 371 is also preferably long enough to facilitatebreaking the frangible stems 159, as will be described more fully below.In one embodiment, the distance D is greater than about 1.27 mm (0.05inches), more preferably the distance D is between about 1.52 mm (0.06inches) and 2.05 mm (0.081 inches, and most preferably is about 2.05 mm(0.081 inches).

The securement force required to secure a probe cover 105 to thethermometer probe 351 can be reduced by increasing the size of theinside of the probe cover body 117 to reduce resistance to insertion ofthe thermometer probe therein. The securement force can be affected byvarious factors. The thermometer 107 shown in FIG. 15A for example,comprises retractable ejection arms 423 designed to engage a shoulder421 on the probe cover. The ejection arms 423 are typically biasedtoward an extended position and engage the shoulder 421 as the probecover 105 is being secured to the probe 351. As the probe 351 isinserted into the probe cover 105, the shoulder 421 pushes the ejectionarms 423 against their bias to a retracted position. An actuator (notshown) on the thermometer 107 allows the user to move the ejection armsto their extended position to push the probe cover 105 off the probe 351after the subject's temperature has been measured. Thus, the amount offorce biasing the ejection arms 423 to their extended positions affectsthe securement force.

The securement force is also affected by the friction between thetubular body 117 of a probe cover 105 and the probe 351 and the amountof force (if any) required to deform the probe cover 105 to make it fiton the thermometer probe 351. For example the probe covers 105 shown inFIGS. 15A and 15B have retention bumps 413 (e.g., three retention bumps)on the inside of the probe cover bodies 117. The retention bumps 413 aredesigned to be received in an annular groove 417 on the thermometerprobe 351 when the probe cover 105 is secured to the thermometer probe,thereby helping retain the probe cover on the thermometer probe. In oneembodiment, the retention bumps 413 are sized so that an inscribedcircle tangent to the apexes of the retention bumps has a radius R1 thatin one embodiment is about 0.28 inches (0.71 cm) and the probe 351 issized so that its radius R2 on the distal side of the groove 417 isabout is about 0.30 inches (0.76 cm). The dimensions can be other thandescribed without departing from the scope of the present invention. Forthis same embodiment, the securement force necessary to attach the probecover 105 to the probe 351 was found on average to be about 2 lbf (8.9N). The force required to release the probe cover 105 from the probe 351was found on average to be about 3 lbf (13.3 N). The detachment forcenecessary to break the frangible connection 157 and release the probecover from the frame 103 ranged from about 3.6 lbf (16 N) to about 4.7lbf (20.9 N). It will be understood that the forces can be other thandescribed without departing from the scope of the present invention.

Another way to design a thermometer system so that the securement forcerequired to secure a probe cover to a thermometer probe is less than thedetachment force is to increase the force required to break thefrangible connection 157 between the probe cover 105 and the frame. Thisis easily controlled by those skilled in the art (e.g., by adjusting thethickness and/or number of the frangible stems).

A plurality of cassettes 101 a, 101 b may be stacked together in themanner described above and placed in a storage container 111 (e.g., abox as shown in FIG. 1) for shipment and/or storage of a supply of probecovers 105. Stacking the cassettes 101 a, 101 b so at least one probecover 105 a on one cassette is nested with a probe cover 105 b of theother cassette, decreases the space required to ship and/or store thecassettes. Preferably, each probe cover 105 of each cassette 101 isnested (either above or below) with a probe cover of another cassette,to make efficient use of space. Although the storage container 111 shownin the drawings is sized to hold two cassettes 101 a, 101 b, it isunderstood that a container could hold many more cassettes, in one ormore stacks.

In one embodiment of a method of the present invention, multiplecassettes are stacked together as described above. For example, thecassettes 101 a, 101 b may be stacked together at a manufacturingfacility and placed in the storage container 111 for shipping. In anyevent, to stack a pair of cassettes 101 a, 101 b, the upper cassette 101a is moved relative to the lower cassette 101 b to a position above thelower cassette. As the upper cassette 101 a is lowered relative to thelower cassette 101 b, the aligning systems 221 a, 221 b of the cassettesand the tapered bodies 117 of the probe covers 105 facilitate bringingthe upper cassette from an orientation relative to the lower cassettethat is different from the orientation of the lower cassette into anorientation relative to the lower cassette that is substantially similarto the orientation of the lower cassette. Alignment of the cassettes 101a, 101 b occurs as described previously herein in reference to FIGS. 8and 8A. Because the probe covers 105 of the upper and lower cassettes101 a, 101 b are supported against pivotal movement relative to theframes 103 a, 103 b, there is no need to manually align the individualprobe covers for stacking.

As the upper cassette 101 a is lowered farther relative to the lowercassette 101 b, the frame 103 a of the upper cassette engages the frame103 b of the lower cassette 101 b and prevents further movement of theupper cassette toward the lower cassette. At this point stacking of thetwo cassettes 101 a, 101 b is complete and the probe covers 105 a of theupper cassette 101 a are held nested within and spaced above the probecovers 105 b of the lower cassette 101 b. Additional cassettes canoptionally be added to the stack of cassettes if desired. The stack ofcassettes 101 a, 101 b is loaded into the storage container 111(optionally with additional stacks of cassettes) and shipped to a healthcare facility, point of retail sale, or other destination.

In order to use the thermometer system 100, a practitioner takes aplurality of stacked probe cover cassettes (e.g., two cassettesincluding the upper and lower cassettes 101 a, 101 b) out of the storagecontainer 111. The practitioner loads the cassettes 101 a, 101 b intothe holder 301 by sliding the lips 283 on the sides of the cassettespast the detents 317 of the holder 301 so that the detents are receivedin the receptacles 281 to snap the lower cassette into the base and tosnap the upper cassette into the stacked relation with the lowercassette, as described above. The cassettes 101 a, 101 b can be stackedfirst and then loaded into the holder 301 together or they can be loadedinto the holder sequentially. As the cassettes 101 a, 101 b snap intoplace, the user hears an audible click and/or feels a tactilelyperceptible pulse when the frame 103 a of the lower cassette 101 bcontacts the upper surface 311 of the base 303 in the holder 301.Likewise, if the user snaps the upper cassette 101 a into the holder 103after the lower cassette 101 b, the user hears an audible click and/orfeels a tactilely perceptible pulse when the frame 103 a of the uppercassette contacts the upper surface 155 b of the lower cassette 101 b.These clicks and/or pulses indicate that the cassettes 101 a, 101 b areproperly stored in the holder 301. The retaining system 315 of theholder 301 releasably holds the stacked cassettes 101 a, 101 b in theholder. Thus, if a probe cover 105 secured to the tympanic thermometer107 accidentally catches on a frame 103 of the cassette 101 when thethermometer is pulled away from the holder 301, the cassette will beheld in place and not pulled out with the probe cover.

Because the probe covers 105 b of the lower cassette 101 b are supportedagainst pivotal movement relative to the frame 103 b of the lowercassette, there is no need to manually align the probe covers toposition them for receipt in the wells 305 of the base 303. Likewise, ifthe cassettes 101 a, 101 b are loaded sequentially, there is no need tomanually align the individual probe covers 105 a of the upper cassetteto stack it on top of the lower cassette in the holder 301. After thecassettes 101 a, 101 b are loaded in the holder 301, the tympanicthermometer 107 may be placed on the holder 301 on top of the cassettes,as shown in FIGS. 1 and 13-14, until it is needed.

As shown in FIGS. 16A-16D, when the practitioner needs to take thetemperature of a subject, he or she removes the thermometer 107 from theholder 301 and inserts the thermometer probe 351 into the opening at theproximal end of one of the probe covers 105 a of the upper stackedcassette 101 a. Because the frangible connection 157 resists pivotalmovement of the probe cover 105 a relative to the frame 103 a, the probecover tends to urge the thermometer probe 351 into alignment with theprobe cover, facilitating insertion of the probe into the probe coverwhen the probe is slightly out of alignment when the insertion begins.The probe cover 105 a is secured to the thermometer 107 by applying asecurement force to the thermometer probe to snap the retention bumps413 into the annular groove 417 of the probe 351 and push the ejectionarms 423 to their retracted position. Because the securement force isless than the detachment force, the probe cover 105 a is still attachedto the frame 103 a when it is secured to the thermometer probe 107. Uponsecurement of the probe cover 105 a to the thermometer probe 107, thefirst annular shoulder 365 at the distal end of the thermometer body 357engages the proximal end 367 of the probe cover 105 a, therebysubstantially preventing further insertion of the probe into the probecover. As the practitioner continues to exert force tending to move thethermometer 107 in the direction of insertion, the first annularshoulder 365 applies a detachment force to the probe cover 105 a thatbreaks the frangible connection 157 between the probe cover and theframe 103 a, thereby detaching the probe cover from the cassette 101 a.When the frangible connection 157 breaks, there is an abrupt decrease inresistance to movement of the thermometer 107 in the direction ofinsertion. The practitioner senses this decrease in resistance. Uponfeeling the release of the probe cover 105 a from the cassette 101 a,the practitioner knows that the probe cover is fully secured to thethermometer probe 351, that the probe cover has been detached from thecassette, and that the thermometer 107 is ready for use.

Although it is theoretically possible that the practitioner will be ablestop movement of the thermometer 107 after release of the probe cover105 a from the frame 103 a before it contacts anything else, most of thetime (e.g., absent extraordinary reaction time) the relatively abruptdecrease in resistance to thermometer movement will result inacceleration of the thermometer toward the probe cover 105 b of thelower cassette 101 b. However, the thermometer 107 (e.g., the secondannular shoulder 371) contacts the frame 103 a of the upper cassette 101a (e.g., the web 171, longitudinal supports 125, and possibly one of theend walls 131 depending on the position of the probe cover 105 a in itsrow) upon movement of the thermometer farther in the direction ofinsertion before either the thermometer or the probe cover securedthereto detach the underlying probe cover 105 b from the lower cassette101 b. The frame 103 a prevents the thermometer 107 and the probe cover105 a secured thereto from moving far enough into the opening to detachor damage the probe cover 105 b of the lower cassette 101 b, andpreferably prevents the thermometer and the probe cover secured theretofrom contacting the underlying probe cover 105 b. The distance D thatthe first annular shoulder 365 projects from the second annular shoulder371 is particularly selected to avoid detaching or damaging the probecover 105 b of the lower cassette 101 b. In the illustrated embodiment,the distance D is about 2.05 mm (0.081 inches). Because the firstannular shoulder 365 engages the probe cover 105 a, it in combinationwith the engagement of the second annular shoulder 371 with the frame103 a controls the length of movement of the probe cover 105 a downwardtoward the second probe cover 105 b. However, the distance D has also becarefully selected to be long enough to produce a sufficient deformationof the frangible stems 159 to assure breakage of the probe cover 105 aaway from the frame 103 a without requiring twisting of the probe coveror other extraneous action. The material of the cassettes 101 a, 101 btends to stretch so that unless the stems 159 are deformed enough,breakage of the stems cannot be certain. For this reason, the distance Dof the first annular shoulder 365 has been selected to be as great aspossible without affecting the probe cover 105 b of the lower cassette101 b.

Contact of the second annular shoulder 371 of the thermometer 107 withthe frame 103 a after detachment of the probe cover 105 a from the firstcassette 101 a produces an audible click and/or a tactilely perceptiblepulse, which indicates that the probe cover 105 a is detached from thecassette 101 a and successfully secured to the probe of the thermometer107. The stiffness of the frame 103 a enhances its ability to withstandthe securement force, the detachment force, and the impact force whenthe thermometer 107 engages the frame after detachment of the probecover 105 a therefrom without damaging or releasing any of the otherprobe covers 105 a, 105 b of either cassette 101 a, 101 b with onlyminimal or no external support.

The thermometer 107 is then used to take the subject's temperature withthe probe cover 105 a providing a sanitary barrier between the subjectand the thermometer probe. After use with one subject, the probe cover105 a is removed from the thermometer probe 107 and discarded. When thepractitioner needs to take another subject's temperature, he or sherepeats the process with another probe cover 105 a of the upper cassette101 a. When all the probe covers 105 a of the upper cassette 101 a havebeen used and discarded, the practitioner grips the upper cassette byits grip 271 a through the cutaways 331 in the housing 307 of the holder301. Although this is not believed to be necessary in the illustratedembodiment, the practitioner may also grip the lower cassette 101 b byits grip 271 b through the cutaways 331 in the housing 307 to hold it inthe holder 301. However, it may not be necessary to hold the underlyinglower cassette 101 b if the retaining system 315 and/or gravity providesufficient force to separate the cassettes 101 a, 101 b. Either way, thepractitioner pulls the upper cassette 101 a out of the holder 301 by itsgrip 271 a and discards the now empty cassette.

To take the temperature of the next subject, the practitioner insertsthe thermometer probe 107 into one of the probe covers 105 b of thelower cassette 101 b, secures it to the probe, and detaches it from theframe 103 b in substantially the same way as was done for the uppercassette 101 a, as shown in FIGS. 17A-17D. Because there are nounderlying probe covers, there is no need to worry that the thermometer107 will accidentally detach or damage any underlying probe covers uponrelease of the probe cover 105 b from the frame 103 b. However, it isdesirable to prevent the distal end of the thermometer probe 107 and theprobe cover 105 b attached thereto from contacting the bottom of thewell 305 because that would be hard on the thermometer probe and mightdamage the film 115 of the probe cover. However, the frame 103 b of thelower cassette 101 b engages the thermometer 107 in substantially thesame way as the frame 103 a of the upper cassette 101 a to limitmovement of the thermometer in the direction of insertion afterdetachment of the probe cover and produces an audible click indicatingthat the probe cover 105 b is detached from the lower cassette 101 b andsuccessfully secured to the probe of the thermometer 107. Thus, theupper surface 155 b of the lower cassette 101 b also stops movement ofthe thermometer 107 in the direction of insertion before the distal endof the thermometer probe and/or the probe cover 105 b secured theretocontact the bottom of the well 305.

When all the probe covers 105 b of the lower cassette 101 b have beenused and discarded, the practitioner grips the lower cassette by itsgrip 271 b through the cutaways 331 in the housing 307 and pulls thelower cassette out of the holder 301. The now empty lower cassette 101 bis then discarded. The practitioner may then get another set ofcassettes out of the storage container 111 (or another container) andsnap them into the holder 301 to repeat the process.

The probe covers of a cassette can vary from the probe covers shown inthe exemplary embodiment shown and described above. For example, theprobe covers can be constructed from other materials. Further, the probecovers can be constructed to have a different configuration from theprobe covers of the exemplary embodiment. If desired, the film portionof the probe covers can be integrally formed as one piece with the bodyrather than a film that is formed separately from the body. Virtuallyany probe cover manufactured in an injection molding process can bereleasably attached to a frame to form a cassette that is within thescope of the present invention.

The frame can have virtually any configuration the permits releasableattachment of a plurality of probe covers thereto without departing fromthe scope of the invention. For example, the probe covers can bearranged differently, such as in rows differing in number or orientationfrom the embodiment described above, in other geometric configurations(e.g., a hexagonal pattern), and/or without being organized in any rowswithout departing from the scope of the invention. Moreover, the probecovers can be positioned laterally of the frame (e.g., on the outside ofthe cassette) without departing from the scope of the invention.

Further, the exemplary cassette shown and described above comprises aplurality of reinforcing structures (e.g., the web, cross braces,flanges and the plurality of intersections of three substantiallyorthogonal walls thereof) which are arranged to provide stiffness to theframe of the cassette. It is recognized that some or all of thesefeatures can be omitted without departing from the scope of theinvention. Likewise, different reinforcing structures and/or a differentarrangement of reinforcing structures can be used to stiffen the frameif desired without departing from the scope of the invention. Further,it is possible to obtain many advantages of the invention without anystiffness enhancing features being included in the frame.

The guide wedge of the particular aligning system shown in the drawingsits narrower at its top and the notch is wider end at its bottom,however, it is possible to construct an aligning system having a wedgethat is narrower at its bottom and a notch that is wider at its topwithout departing from the scope of the invention. Likewise, it is notnecessary to have the aligning system at the end of the cassette.

Although the exemplary method shown and described above involvesstacking multiple cassettes that are substantially identical to eachother, it is contemplated that one or more cassettes in a stack ofcassettes could be different from one or more other cassettes in thestack without departing from the scope of the invention. For example,one cassette (e.g., a cassette intended to be on the bottom of a stack)could be constructed differently to facilitate that cassette's abilityto perform a particular function that is not required of all thecassettes (e.g., to engage a base that receives the stack of cassettes).Moreover, some advantages of the invention could be attained by stackingone or more different sized cassettes on top of a lower cassette withoutdeparting from the scope of the invention. Further, it is possible toobtain some of the benefits of the invention (e.g., the more pronouncedtactile feedback while inserting a thermometer probe into a probe coverand detaching the probe cover from the frame) without any stacking.

Accordingly, it will be understood that various modifications may bemade to the embodiments disclosed herein. Therefore, the abovedescription should not be construed as limiting, but merely asexemplification of the various embodiments. Those skilled in the artwill envision other modifications within the scope and spirit of theclaims appended hereto.

1. A cassette comprising a frame and a plurality of tympanic thermometerprobe covers, each of the probe covers being releasably attached to theframe by at least one frangible connection, said at least one frangibleconnection being constructed allow the respective probe cover to bedetached from the frame upon application of a detachment force and tosupport the respective probe cover against pivoting relative to theframe when it is releasably attached to the frame.
 2. A cassette as setforth in claim 1, wherein said at least one frangible connectioncomprises at least three frangible stems connecting the respective probecover to the frame at different locations.
 3. A cassette as set forth inclaim 2, wherein the frangible stems are spaced substantiallyequidistant from one another around a circumference of the respectiveprobe cover.
 4. A cassette as set forth in claim 1, wherein the framecomprises a plurality of longitudinal supports supporting a plurality ofprobe covers arranged in a row, the frame further comprising at leastone cross brace connecting the longitudinal supports between two of theprobe covers.
 5. A cassette as set forth in claim 1, the probe coversbeing arranged in at least one row, the cassette comprising a pluralityof stiffness enhancing supports, said plurality of supports including atleast longitudinal two supports extending generally in the direction ofsaid at least one row and at least one cross brace connecting the atleast two longitudinal supports, said at least one cross brace beingpositioned between two of the releasably attached probe covers in saidat least one row to resist deflection of the frame when the probe coversare detached from the frame.
 6. A cassette as set forth in claim 5,wherein the frame further comprises a web extending laterally from oneof the longitudinal supports, the web, cross brace and longitudinalsupport intersecting at a location, each of the web, cross brace andlongitudinal support being oriented in a different plane at saidlocation.
 7. A cassette as set forth in claim 6, wherein each of theweb, cross brace and longitudinal support are mutually orthogonal to oneanother at said location.
 8. A cassette as set forth in claim 1, whereinthe frame comprises a side wall and a web projecting inwardly of theside wall, the web including at least one spur projecting generallybetween adjacent probe covers, at least one of the frangible connectionsextending from the spur to one of the adjacent probe covers.
 9. Acassette comprising a frame and a plurality of tympanic thermometerprobe covers releasably attached to the frame, wherein each probe coveris attached to the frame by a frangible connection, the probe coversbeing configured for attachment to a probe of a tympanic thermometerupon application of a securement force, the frangible connection beingconfigured to release the respective probe cover from the frame uponapplication of a detachment force that is greater than the securementforce whereby the probe covers can be held by the frame while attachingto the thermometer probe and detached from the frame after the probecover is attached to the thermometer probe.
 10. A cassette as set forthin claim 9, wherein the frangible connection of each of the probe coverscomprises at least three frangible stems.
 11. A cassette as set forth inclaim 9, wherein the frame is configured to limit movement of thethermometer probe and detached probe cover relative to the frame in thedirection of insertion after detachment of the probe cover from theframe.
 12. A cassette as set forth in claim 9, wherein the framecomprises a plurality of longitudinal supports supporting a plurality ofprobe covers arranged in a row, the frame further comprising at leastone cross brace connecting the longitudinal supports between two of theprobe covers.
 13. A cassette as set forth in claim 9, the probe coversbeing arranged in at least one row, the cassette comprising a pluralityof stiffness enhancing supports, said plurality of supports including atleast longitudinal two supports extending generally in the direction ofsaid at least one row and at least one cross brace connecting the atleast two longitudinal supports, said at least one cross brace beingpositioned between two of the releasably attached probe covers in saidat least one row to resist deflection of the frame when the probe coversare detached from the frame.
 14. A cassette as set forth in claim 13,wherein the frame further comprises a web extending laterally from oneof the longitudinal supports, the web, cross brace and longitudinalsupport intersecting at a location, each of the web, cross brace andlongitudinal support being oriented in a different plane at saidlocation.
 15. A cassette as set forth in claim 14, wherein each of theweb, cross brace and longitudinal support are mutually orthogonal to oneanother at said location.
 16. A cassette as set forth in claim 9 whereinthe frame comprises a side wall and a web projecting inwardly of theside wall, the web including at least one spur projecting generallybetween adjacent probe covers, at least one of the frangible connectionsextending from the spur to one of the adjacent probe covers.
 17. Acassette as set forth in claim 9 in combination with a second cassettecomprising a second frame and a second plurality of tympanic thermometerprobe covers, the second plurality of probe covers being releasablyattached to the second frame, wherein at least one of the releasablyattached probe covers of the first cassette is nested with at least oneof the releasably attached probe covers of the second cassette.
 18. Acombination as set forth in claim 17, wherein the first and secondcassettes are substantially identical.
 19. A combination as set forth inclaim 18, wherein the first and second cassettes are configured tomaintain spatial separation between the nested probe covers.
 20. Acombination as set forth in claim 17 further comprising the tympanicthermometer, the thermometer comprising a probe and a housing includinga proximal annular shoulder and a distal annular shoulder extending fromthe proximal annular shoulder, the probe extending from the distalannular shoulder, the proximal annular shoulder being sized and shapedto engage the frame of the first cassette upon continued movement of thethermometer after one of the probe covers of the first cassette isdetached by application of the detachment force by the thermometer tosaid one probe cover, the distal shoulder extending from the proximalshoulder a distance of about 1.52 mm (0.060 inches) and about 2.05 mm(0.081 inches) to facilitate breakage of the frangible connection ofsaid one probe cover to the first cassette.
 21. A method of securing aprobe cover to a probe of a tympanic thermometer, the method comprising:inserting the probe into an open end of the probe cover while the probecover is releasably attached to a frame, the frame having a plurality ofother probe covers releasably attached thereto; moving the probe intothe probe cover until the probe cover is deformed by application of atleast a securement force so as to resiliently bear against the probe forsecuring itself to the probe while the probe cover remains connected tothe frame; and then continuing to move the probe into the probe coverwith at least a detachment force that detaches the probe cover from theframe, the detachment force being greater than the securement force. 22.A method as set forth in claim 21 wherein the step of continuing to movethe probe includes breaking a frangible connection between the probecover and the frame.
 23. A method as set forth in claim 22 furthercomprising contacting the frame with the tympanic thermometer afterdetaching the probe cover from the frame.
 24. A method as set forth inclaim 23, wherein contacting the frame with the tympanic thermometerproduces an audible click to verify that the probe cover connected tothe probe can be withdrawn with the probe cover from the frame.
 25. Amethod as set forth in claim 22 wherein the step of moving the probeinto the probe cover includes deforming the probe cover until at leastone retention bump engaging the probe snaps into an annular groove inthe probe.